Data / Medical devices / United States / Techlab, Inc.
Techlab, Inc.: FDA-registered device maker in Radford, VA, United States, 23 510(k) clearances
Techlab, Inc. is registered with the FDA (registration 3009935129) in Radford, VA, United States. It lists 10 device types. The FDA files 23 510(k) clearances under its listings, the newest dated August 21, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009935129
- Address
- 20 Corporate Drive, Radford, VA, United States, 24141
- Owner or operator
- TECHLAB, INC. (9001581)
- Roles
- Manufacturer
- First device listed
- May 19, 1994
- Registered through
- 2026
- Brand names listed
- ASCA-CHEK, C. DIFF CHEK -60, C. DIFF QUIK CHEK, C. DIFF QUIK CHEK COMPLETE, C. DIFFICILE TOX A/B II, CAMPYLOBACTER CHEK, CAMPYLOBACTER QUIK CHEK, CRYPTOSPORIDIUM II and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | NBT | 2 | Manufacturer | accessdata.fda.gov |
| Antigen, C. Difficile | MCB | 1 | Manufacturer | accessdata.fda.gov |
| Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | KHW | 2 | Manufacturer | accessdata.fda.gov |
| Antigens, All Types, Escherichia Coli | GMZ | 1 | Manufacturer | accessdata.fda.gov |
| Campylobacter Spp. | LQP | 1 | Manufacturer | accessdata.fda.gov |
| Cryptosporidium Spp. | MHJ | 2 | Manufacturer | accessdata.fda.gov |
| Giardia Spp. | MHI | 2 | Manufacturer | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Manufacturer | accessdata.fda.gov |
| Lactoferrin, Antigen, Antiserum, Control | DEG | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Clostridium Difficile Toxin | LLH | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2018 | K181400 | H. PYLORI CHEK | LYR | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| August 21, 2018 | K181379 | H. PYLORI QUIK CHEK | LYR | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| January 22, 2018 | K173219 | CAMPYLOBACTER CHEK | LQP | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| January 22, 2018 | K173217 | CAMPYLOBACTER QUIK CHEK | LQP | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| July 10, 2017 | K171078 | TRI-COMBO PARASITE SCREEN | MHJ | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| June 7, 2017 | K170728 | E. HISTOLYTICA QUIK CHEK | KHW | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| October 2, 2012 | K121411 | SHIGA TOXIN CHEK | GMZ | Substantially Equivalent | Techlab Inc., Corporate Research Center | accessdata.fda.gov |
| October 2, 2012 | K121364 | SHIGA TOXIN QUIK CHEK | GMZ | Substantially Equivalent | Techlab Inc., Corporate Research Center | accessdata.fda.gov |
| August 18, 2011 | K103673 | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK | MHI | Substantially Equivalent | Techlab Inc., Corporate Research Center | accessdata.fda.gov |
| March 26, 2009 | K082499 | C. DIFF QUIK CHEK COMPLETE | LLH | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| December 4, 2007 | K071712 | LEUKO EZ VUE | DEG | Substantially Equivalent | Techlab Inc., Corporate Research Center | accessdata.fda.gov |
| November 7, 2007 | K071711 | ASCA-CHEK | NBT | Substantially Equivalent | Techlab Inc., Corporate Research Center | accessdata.fda.gov |
| April 26, 2006 | K053572 | C. DIFF QUIK CHEK | MCB | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| November 17, 2005 | K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK | MHJ | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| November 4, 2005 | K052932 | CRYPTOSPORIDIUM II | MHJ | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| July 25, 2005 | K050891 | TOX A/B QUICK CHEK | LLH | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| October 20, 2004 | K042071 | IBD-SCAN | DEG | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| November 4, 2003 | K033274 | GIARDIA II | MHI | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| July 11, 2003 | K030992 | C. DIFF CHEK - 60 | LLH | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| April 21, 2003 | K030704 | IBD-QUIK CHEK | DEG | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| June 18, 2001 | K011396 | IBD-CHEK | DEG | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| November 22, 2000 | K003306 | C. DIFFICILE TOX A/B II | LLH | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
| December 21, 1999 | K994101 | E. HISTOLYTICA II | KHW | Substantially Equivalent | Techlab, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Helicobacter Pylori
- All makers of Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- All makers of Antigen, C. Difficile
- All makers of Cryptosporidium Spp.
- All makers of Lactoferrin, Antigen, Antiserum, Control
- All makers of Reagents, Clostridium Difficile Toxin
Updated August 21, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.